MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD INSYTE AUTOGUARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 20 G X 1.16 IN

Patient Problem Discomfort (2330)

Event Date 10/10/2023

Event Type  malfunction  

Event Description

Rn (registered nurse) reported that after inserting the angiocath needle, the catheter would not advance.They also reported difficulty inserting the needle, stating that it seemed like the needle was thicker on the end leading to resistance of insertion and threading of catheter.Iv was removed.No patient harm noted except temporary discomfort.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 18343918
• MDR Text Key: 330715839
• Report Number: 18343918
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20 G X 1.16 IN
• Device Lot Number: 3214010
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female